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| Name | Class |
|---|---|
| Universidade da Coruña | OTHER |
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The purpose of this study is to assess different hybrid natural orifice transluminal endoscopic surgery techniques in management of colorectal cancer as regard: feasibility of the technique, short term oncologic outcome and functional outcome.
Intervention will be done by conventional laparoscopy and transanal endoscopy (TEO or Gelpoint platform), patients are divided into two arms to compare different natural orifice techniques in resection of colorectal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Natural orifice specimen extraction | Experimental | Conventional laparoscopic resection of colorectal cancer with natural orifice specimen extraction |
|
| Laparoendoscopic resection | Experimental | Laparoscopic assisted transanal endoscopic resection of rectal cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| natural orifice specimen extraction | Procedure | Conventional laparoscopic resection of colorectal cancer is done then specimen is extracted through natural orifice (anal or vaginal orifice). |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility | Rate of conversion to classic laparoscopy or to open laparotomy. | 24 hour |
| operative time | time taken from starting operation till patient wake up | 24 hour |
| Operative blood loss | measured in milliliter | 24 hour |
| Wound complications | infection-dehiscence | two week |
| Major intraoperative complications | bleeding -organ injury | 24 hour |
| Major postoperative complications | leak-bleeding | two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adequacy of lymphadenectomy | Number of lymph nodes retrieved | one month |
| Grading of quality and completeness of mesorectal excision | It is a composite outcome where result will appear as either complete, near complete or incomplete. Criteria in (shape, coning, presence of defects and circumferential safety margin) will be integrated to categorize it. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Islam H Metwally, M.Sc | Contact | 01002985865 | 02 | dr.islamo@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jose F Noguira, MD | Head of general and digestive surgery department, CHUAC, universidade da Coruna | Study Director |
| Sherif Z Kotb, MD | Professor of surgical oncology, Oncology center Mansoura University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology center Mansoura University | Recruiting | Al Mansurah | Dakahlia Governorate | 35516 | Egypt |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Laparoendoscopic resection | Procedure | Endoscopic phase: Transanal platform is inserted into the rectum, and pneumorectum is established. The lumen is occluded below the level of the tumor. The avascular ''oncologic'' presacral plane is entered posteriorly, and dissection proceeds cephalad in the total mesorectal excision planes. Next, the abdominal cavity is entered at the peritoneal reflection. The superior rectal artery is divided. The rectal stump then is reflected into the abdominal cavity, and retrograde dissection is performed until the procedure is limited by instrument length. Laparoscopic phase: Colon mobilization, lymph node dissection, and mesenteric excision are performed laparoscopically. Mobilization of the splenic flexure is done if needed. |
|
| one month |
| Longitudinal safety margin | either free or infiltrated with tumor by histopathology examination. | one month |
| short term oncologic outcome | incidence of local and distant outcomes and disease free survival | 6 months - one year |
| Functional outcome | assessing fecal incontinence using Kirwan's grading score | 3 months |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |